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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06831812




Registration number
NCT06831812
Ethics application status
Date submitted
12/02/2025
Date registered
18/02/2025
Date last updated
20/05/2025

Titles & IDs
Public title
Phase I Clinical Study of AV-1959R: Abeta-targeting Anti-Alzheimer's Vaccine
Scientific title
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of AV-1959R in Healthy Participants
Secondary ID [1] 0 0
AU-AV1959R-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Alzheimer Disease (AD) 0 0
Alzheimers Disease Prevention 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - AV-1959R (Abeta vaccine)

Experimental: Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1 - Participants receive 100 µg of AV-1959R with the adjuvant via intramuscular injection

Experimental: Arm 2: Placebo (Adjuvant Only) - Cohort 1 - Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection

Experimental: Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2 - Participants receive 300 µg of AV-1959R with the adjuvant via intramuscular injection

Experimental: Arm 4: Placebo (Adjuvant Only) - Cohort 2 - Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection


Treatment: Other: AV-1959R (Abeta vaccine)
AV-1959R is an investigational adjuvanted vaccine designed to induce a targeted immune response against beta-amyloid (Aß) to support the primary prevention of Alzheimer's disease and the treatment of asymptomatic preclinical Alzheimer's disease. It is administered intramuscularly (IM) at doses of 100 µg or 300 µg on Weeks 0, 4, and 14, in combination with the adjuvant.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of AV-1959R compared to placebo
Assessment method [1] 0 0
Safety and tolerability will be assessed by the incidence and severity of adverse events (AEs), serious adverse events (SAEs), and injection site reactions following intramuscular administration of AV-1959R at 100 µg and 300 µg doses. Safety will also be evaluated through clinical laboratory tests, vital signs, physical examinations, and MRI scans at predefined time points.
Timepoint [1] 0 0
Up to 26 weeks
Secondary outcome [1] 0 0
Immunogenicity of AV-1959R: Anti-Aß antibody response
Assessment method [1] 0 0
Immunogenicity will be assessed by quantifying anti-Aß antibody levels in plasma samples collected at predefined study visits. Antibody titers will be determined using a validated ELISA method.
Timepoint [1] 0 0
Up to 26 weeks

Eligibility
Key inclusion criteria
* Healthy male or female adults, 40-60 years old.
* BMI 18.0-32.0 kg/m².
* No significant medical conditions or abnormal MRI, ECG, or lab tests.
* Signed informed consent and ability to follow study procedures.
* Females must be postmenopausal or surgically sterile.
* Males must use contraception or be vasectomized.
Minimum age
40 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* History of Alzheimer's, stroke, or neurodegenerative disease.
* MRI abnormalities, such as infarcts or microbleeds.
* Serious illness, surgery, or hospitalization in the last 4 weeks.
* Significant heart, lung, liver, kidney, or immune disorders.
* Recent drug/alcohol abuse or severe allergies.
* Abnormal lab tests (e.g., high liver enzymes, kidney dysfunction, HIV, Hepatitis B/C positive).
* Use of investigational drugs or amyloid/tau therapies in the last year.
* Chronic use of immunosuppressants, anticoagulants, or blood products.
* Pregnant, breastfeeding, or women of childbearing potential.
* Recent blood donation (>400 mL) in the last 30 days.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Arvax - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Nuravax, Inc.
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Arvax
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Hovhannes Madoyan, MD
Address 0 0
Arvax
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06831812